New Details in Schizophrenia Treatment Trial Emerge

BETHESDA, Md., March 1, 2007--Two new studies from the Clinical
Antipsychotic Trials for Intervention Effectiveness (CATIE) provide
more insights into comparing treatment options, and to what extent
antipsychotic medications help people with schizophrenia learn
social, interpersonal and community living skills. The new studies
are published in the March 2007 issue of the American Journal of
Psychiatry. CATIE, a $42.6 million, multi-site study, was funded by
the National Institutes of Health's National Institute of Mental
Health (NIMH).

Comparing Newer Antipsychotic Medications After Older One
Fails

Quetiapine, and to some extent olanzapine, may be more effective
than risperidone among patients who were originally taking, but had
to discontinue, perphenazine—an older, first generation
antipsychotic medication. However, patient responses varied
considerably.

"CATIE continues to fine-tune our understanding of how our
arsenal of antipsychotic medications work in real-world settings,
but it also is revealing to us what questions we still must
address," said NIMH Director Thomas R. Insel, M.D.

Of the 257 patients who were initially randomized to
perphenazine in the CATIE study, 192 discontinued the medication
for various reasons, including ineffectiveness and intolerable side
effects. Among those who discontinued, 114 agreed to be
re-randomized to one of three newer antipsychotic
medications—olanzapine, quetiapine or risperidone.

T. Scott Stroup, M.D., MPH, of the University of North Carolina
at Chapel Hill, and colleagues compared the effectiveness of the
medications by determining how long patients stayed on their
assigned medication. Those taking quetiapine stayed on the
longest—averaging about ten months before discontinuing.
Those taking olanzapine discontinued after an average of about
seven months, and those taking risperidone discontinued after an
average of four months.

Although the discontinuation results suggest that olanzapine was
generally on par with quetiapine, patients taking olanzapine
experienced more side effects. While none of those taking
quetiapine discontinued use due to weight gain or metabolic side
effects, 13 percent of those assigned to olanzapine discontinued it
due to weight gain or metabolic problems, and 5 percent of those on
risperidone did so.

"These results reinforce the fact that finding the most
effective medication for each patient sometimes means trying
multiple medications," said Dr. Stroup. "They remind us of the
considerable variability in clinical circumstances and of our need
to be responsive to an individual's needs and preferences."

Schizophrenia Patients' Social and Community Living Skills
Improve Modestly While on Antipsychotic Medications

Patients with schizophrenia taking antipsychotic medications
experience modest improvements in social, interpersonal and
community living (psychosocial) skills, regardless of what
antipsychotic medication they are taking.

Improvements in psychosocial skills among patients with
schizophrenia have been notoriously difficult to achieve, even when
the more disruptive symptoms of the disease can be controlled.
"Helping patients with schizophrenia restore their psychosocial
functioning remains a challenge," said NIMH Director Thomas R.
Insel, M.D. "These CATIE results reinforce the growing
understanding that we must do a better job of helping patients get
their life skills back on track."

Marvin Swartz, M.D., of Duke University and colleagues evaluated
the social and vocational functioning, interpersonal relationships,
and psychological well-being of 455 participants—about
one-third of all patients in the CATIE study—who completed an
initial evaluation before the study began and were available to
provide data after 12 months of treatment. In the first phase of
the CATIE study, patients were randomly assigned to take either
perphenazine—an older, first-generation antipsychotic
medication—or one of several newer, second-generation
medications (olanzapine, quetiapine, risperidone, or
ziprasidone).

The researchers found that those patients who stuck with their
initial treatment showed some improvement in their psychosocial
functioning, and there were no differences among the medications in
making these gains. The results are consistent with previously
reported CATIE results in which few differences were seen among
perphenazine and the newer, second-generation antipsychotic
medications in effectively reducing symptoms.

The patients who made the greatest gains were the ones with the
poorest community living skills at the beginning of the study, but
they were also more likely to discontinue treatment early in the
process. As noted in previous CATIE reports, many patients
discontinued their initial treatments because of intolerable side
effects or ineffectiveness.

"Over the long run patients are more likely to function better
in the community if they are able to stay on their initial
treatment, especially those who are the most impaired," said Dr.
Swartz. "More intensive rehabilitative interventions and outreach
may help patients stick with their treatment and make greater
gains."

Patients who made few gains in community living skills were
those with higher-level psychosocial skills at the beginning of the
study. Swartz and colleagues posit that patients encountered a
"ceiling effect" at which point additional psychosocial skill
improvement was unlikely without additional rehabilitative
treatment.

"Overall, the findings reiterate the widely held belief that
antipsychotic medications alone are not sufficient in helping
patients make meaningful gains in real-world functioning," said Dr.
Swartz. "Dedicated rehabilitative services that help patients learn
to function at work and in social settings are sorely needed."

The National Institute of Mental Health (NIMH) mission is to
reduce the burden of mental and behavioral disorders through
research on mind, brain, and behavior. More information is
available at the NIMH website.

The National Institutes of Health (NIH) — The Nation's
Medical Research Agency - includes 27 Institutes and Centers and is
a component of the U. S. Department of Health and Human Services.
It is the primary federal agency for conducting and supporting
basic, clinical, and translational medical research, and it
investigates the causes, treatments, and cures for both common and
rare diseases. Visit the NIH website for more information about its
programs.

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